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CTRI Number  CTRI/2022/07/044093 [Registered on: 18/07/2022] Trial Registered Prospectively
Last Modified On: 23/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To compare the effect if samana snehapana using sahacharadi taila with that of dhanwantaram taila in the management of osteoarthritis of knee joint 
Scientific Title of Study   Effect of samana snehapana with sahacharadi taila in comparison to dhanwantaram taila in the management of osteoarthritis of knee joint 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Remya R G 
Designation  PG scholar 
Affiliation  Government Ayurveda college Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college panchakarma hospital Poojappura Thiruvananthapuram
Department of Panchakarma Government Ayurveda college panchakarma hospital Poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India 
Phone  6383343078  
Fax    
Email  drremyarems@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T K Sujan 
Designation  Professor & HOD  
Affiliation  Government Ayurveda college Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college panchakarma hospital poojappura Thiruvananthapuram
Department of Panchakarma Government Ayurveda college panchakarma hospital poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India 
Phone  9447071215  
Fax    
Email  drtksujan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T K Sujan 
Designation  Professor & HOD  
Affiliation  Government Ayurveda college Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda college panchakarma hospital poojappura Thiruvananthapuram
Department of Panchakarma Government Ayurveda college panchakarma hospital poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India 
Phone  9447071215  
Fax    
Email  drtksujan@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda college panchakarma hospital poojappura 
 
Primary Sponsor  
Name  Government Ayurveda college panchakarma hospital poojappura Thiruvananthapuram 
Address  Government Ayurveda college panchakarma hospital poojappura Thiruvananthapuram 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Remya R G  Government Ayurveda college panchakarma hospital   Government Ayurveda panchakarma hospital Department of panchakarma Room no 1 Poojappura
Thiruvananthapuram
KERALA 		 6383343078

drremyarems@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Ayurveda college Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pAcana, पाचन (Procedure Reference: Sarangdhara Samhita, Procedure details: procedure that enhances the digestion of the patient)
(1) Medicine Name: Gandharvahastadi kashayam, Reference: sahasrayogam, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 90(ml), Frequency: bd, Duration: 5 Days
2Intervention ArmProcedure-dIpana , दीपन (Procedure Reference: Sarangdhara Samhita, Procedure details: Procedure that enhances digestive fire.)
(1) Medicine Name: Vaiswanaram Churna, Reference: Astanga Hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 5 Days
3Intervention ArmProcedure-AByantarasnehaH , आभ्यन्तर स्नेहः Pradhan Karma(Procedure Reference: Ashtanga hridaya, Procedure details: Internal administration of oil)
(1) Medicine Name: Sahacharadi taila, Reference: Ashtanga hridaya, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 14 Days
4Comparator ArmProcedure-dIpana , दीपन (Procedure Reference: Sarangadhara Samhita, Procedure details: Procedure to enhance the agni of the patient)
(1) Medicine Name: Vaiswanara Choorna, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 5 Days
5Comparator ArmProcedure-pAcana, पाचन (Procedure Reference: Sarangadhara Samhita, Procedure details: Procedure to enhance the digestion of the patient)
(1) Medicine Name: Gandharvahastadi kashayam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 90(ml), Frequency: bd, Duration: 5 Days
6Comparator ArmProcedure-AByantarasnehaH , आभ्यन्तर स्नेहः (Procedure Reference: Ashtanga Hridaya, Procedure details: Internal administration of oil)
(1) Medicine Name: Dhanwantaram Taila, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) participants of both sex among age group 40-60 years of age.
2) Diagnosed cases of OA knee on the basis of clinical signs and symptoms and according to Kellgren and Lawrence system of classification of OA knee up to grade 3.
3) Participants who are indicated for snehapana
4) Participants with informed consent 
 
ExclusionCriteria 
Details  1) Inflammatory arthritis
2) Congenital abnormalities
3) Participants with knee replacement implants
4) Participants with uncontrolled diabetes and hypertension, severe liver and renal disorder, malignancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
WOMAC Osteoarthritis index
TUG Test scoring of timed up and go test 		 6th day, after treatment 20th day,follow up 35th day, 65th day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   21/07/2022 
Date of Study Completion (India) 22/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/06/2023 
Estimated Duration of Trial   Years="1"
Months="8"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Osteoarthritis of knee joint is a common progressive multifactorial joint disease and is characterized by chronic pain and functional disability. OA is the second most common rheumatologic problem of 22% to 39% in India. OA is common in women than men, but the prevalence increase dramatically with age. In Ayurveda OA knee may be well considered as Sandhigata vata a type of VataVyadhi affecting the sandhi, explained by all the acharayas. As vata is predominantly vitiated, Snehanam is one of the effective treatment to treat vitiated vata. Among the snehana therapy, Samana snehapana could be very effective treatment modality. Sandhigata vata / OA knee is a condition where cartilage in the knee degenerates results in bone rubbing together and creating stiffness, pain and impaired movements. Sahacaradi taila, in Astanga hridaya, Astanga sangraha which is mentioned in Vatavyadhi chikitsa and it is very effective in adha – kaya vata rogas. The objectives of this study is to compare the effect of samana snehapana with Sahacaradi taila and Dhanwantaram taila in the management of OA knee. The study is comparative clinical trial with control group. Participants of both sex, aged 40 – 60 years registered in OPD and IPD of Government Ayurveda college Panchakarma Hospital, Trivandrum satisfying the inclusion criteria will be subjected to consecutive sampling and the total of 32 participants will be selected for the study. The data will be collected through observation, clinical case proforma and X-ray. After collecting baseline data, detailed history and examination will be done using clinical case proforma. A total of 32 participants will be selected for the study. They will be subjected to consecutive sampling, divided in to 2 groups (Group A and Group B). In Group A Sahacaradi taila as samana sneha pana will be given for 14 days and Group B, Dhanwantaram taila as samana snehapana will be given for 14 days. Both the groups will be assessed before and after the intervention on 0th day, 6th day, after treatment on 20th day, followup on 35th day and 65th day. The result will be analyzed statistically by using Descriptive and „Mann Whitney U Test‟. Keywords : Osteoarthritis, Sandhigata vata, Samana snehapana, Sahacaradi taila, Dhanwantaram taila. 
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